Kristopher Evon
QA Specialist - Validation at Amgen
- Role
- Qa Specialist - Validation at Amgen
- Location
- West Greenwich, RI, US
- LinkedIn followers
- 500 followers
About Kristopher Evon
Dedicated to ensuring technical understanding and compliance are the foundation of quality decisions. Action orientated Quality leader and collaborator, partnering with all functions in validation, root cause investigations, CAPA solutions, and ensuring technical decisions are compliant. Focused on developing team members’ technical capabilities and promoting a tactful approach to implementing quality judgment. Motivated to drive quality system performance improvements for deviation, CAPA, and laboratory investigations. Expertise in- Root Cause Analysis - Validation- Technical Writing - Program Management– Deviations and CAPAs- Quality Assurance - Team Leadership- QC Laboratory Management- Staff Training
Experience
Qa Specialist - Validation
Jun 2017 — Present · Providence, RI, US
Perform Process Validation in a multi-product manufacturing facility o Process Performance Qualification runs o Purification column/membrane studies o Media/Buffer qualification and hold studies• Partner with Process Development, Process Engineering and Manufacturing for deviation resolution and process improvements• Collaborate with QA disposition to ensure controlled release of product• Provide Quality oversight for all validation areas o Process o Equipment o Cleaning/Steaming o Computer related system
Education
University of Rhode Island - College of Business
MBA, Business Administration and Management, General
2008 — 2011
University of Rhode Island
Bachelor of Science (BS), Biology
1998 — 2002
Skills
- Investigation
- Process Validation
- Quality Management
- Manufacturing
- Quality
- Corrective and Preventive Action (Capa)
- Root Cause Analysis
- Quality Assurance
- Laboratory Skills
- Validation
- Pharmaceutical Industry
- Business Process Improvement
- Sop
- Deviation Management
- Fda
- Computer System Validation
- Capa
- QA Operations
- Continuous Improvement
- Quality System
- Quality Systems
- Cross-Functional Team Leadership
- Deviations
- Project Implementation
- Quality Control
- Gmp
- Standard Operating Procedure (Sop)
- Kt
- U.s. Title 21 Cfr Part 11 Regulation
- Hplc
- Method Development
- Change Control
- Biopharmaceuticals
- Biotechnology
- 21 Cfr Part 11
- Gxp
- Qc
- Technical Writing
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